# K251910: Focal One®

- Pathway: 510(k) (Traditional)
- Applicant: Edap Technomed, Inc.
- Decided: Nov 19, 2025 after 152 days
- Product code: PLP (High Intensity Ultrasound System For Prostate Tissue Ablation)
- Device class: 2
- Regulation: 21 CFR 876.4340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN150011 (2015). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172721: Focal One, Edap Technomed, Inc. (2018) Summary page 5.

## Indications for use
The Focal One® is indicated for transrectal high-intensity focused ultrasound (HIFU) ablation of prostate tissue.

Source page: https://510kreport.com/device/K251910
Methodology: https://510kreport.com/methodology